Kornimate/medical-research-clean huggingface dataset:
intraosseous transcutaneous amputation prosthesis

Conditions: Traumatic Amputation of Lower Extremity

Summary: direct skeletal fixation of prosthetic limbs following trans-femoral amputation - study of an intraosseous transcutaneous amputation prosthesis (itaptm).

the core itap™ design comprises of three discrete sections, the proximal section, which is the intramedullary stem secured into the medullary canal, the soft tissue integration flange and the transcutaneous component that passes through the skin. the device has been designed to be surgically implanted in a one stage procedure. in greater detail: intra-medullary stem - this component is designed to match the natural shape of the canal and is designed using the same principles established and used for the fixation of massive endo-prosthetic replacements. in certain cases a hydroxyapatite ceramic (capo4) coating is used, providing enhanced uncemented fixation. in other cases, depending on the geometry of the intramedullary canal, the stem can be fixed in place using acrylic bone cement.

Eligibility criteria:
inclusion criteria: * trans-femoral amputation * 6 months or more attempted prosthetic rehabilitation (use of walking aids not relevant) * between the ages of 18 to 60 inclusive * length of stump: sufficient bony stock for bony integration (at the investigator's discretion) and sufficient clearance (at the investigator's discretion) from medial joint line to accommodate failsafe device/ adaptor and knee mechanism * suitable soft tissues to perform the operative procedure * flexion deformity (ffd) at hip no more than 15° * normal range of flexion and adduction other than ffd * oxford grade 4 muscle power in all groups around hip * normal contralateral leg function * psychologically suitable (as deemed by screening process) * sufficient standard of english to understand the patient information sheet and general study requirements * ability to understand and comply with study requirements - notably study timelines and additional clinic visits * patients willing to take part in the study and sign the informed consent form exclusion criteria: * radiotherapy to target limb at any time * chemotherapy within the preceding 12 months * cognitive impairment likely to affect participation * pre-existing ipsilateral hip pathology * limited cardiorespiratory reserve / inability to walk at normal pace * any significant co-morbidity that, in the investigator's opinion, is likely to affect outcome (e.g. osteoporosis, heart disease, peripheral vascular disease, obesity or unrelated cancer) * any co-morbidity in the contra-lateral leg that precludes walking * any significant previous infection within the previous 12 months, such as apical stump sepsis or dental sepsis * mrsa * using another silver-dosed medical device/treatment * patients with hypersensitivity to silver * concurrent medico-legal proceedings taking place * patients currently included in other clinical trials

Keywords: osseointegration direct skeletal attachment
artificial intelligence in depression - medication enhancement

Conditions: Depression

Summary: this study will determine the safety and potential effectiveness of a digital health platform aimed at improving treatment outcomes for patients with depression by assisting physicians with clinical decision making about depression treatment.


Eligibility criteria:
patient inclusion criteria: * diagnosed with major depressive disorder by a physician using dsm-v criteria * able to provide informed consent * patients must confirm that they are comfortable being treated for depression by their physician, who may propose a range of treatment options, such as medications or psychotherapies, consistent with best practice guidelines for depression which are included in the application. physicians will be required, as in usual practice, to explain treatments to patients and patients will be able to give and withdraw consent for treatment in general or for specific treatments as in usual practice. patient exclusion criteria: * bipolar disorder of any type * inability or unwillingness of the individual to give informed consent * inability to manage patient in an outpatient setting (i.e. imminent suicidality) * active major depression is not the main condition being treated (i.e. the patient has depressive symptoms in the context of severe substance abuse or a psychotic disorder, but a primary diagnosis of major depressive episode (mde) cannot be made or would result in inappropriate care). * inability to use the tool (i.e. patient cannot interface with a mobile phone or computer due to delirium, or another medical condition)\* \*note that for patients who do not have access to mobile or desktop devices but are able to use them or to be trained to use them, these will be provided to them at no cost. physician inclusion criteria: * any family doctor/primary care physician or psychiatrist accredited in canada or the usa who treats patients with depression on at least a monthly basis, as well as residents from these specialities supervised by a participating physician * able to provide informed consent * comfortable prescribing the range of potential treatments which could have probabilities provided for them by the cda no physician exclusion criteria

Keywords: depression treatment selection decision support artificial intelligence (ai) machine learning (ml)
neva retrospective comparative sr study

Conditions: Stroke Acute

Summary: to compare safety and effectiveness of neva stent retriever (sr) to control sr in the treatment of stroke caused by large vessel occlusion. the main questions it aims to answer are: how do recanalization rates for neva sr compare with those of the control sr? how does neva sr safety compare with control sr safety?

nitro is a multicenter, retrospective, comparative, non-inferiority, cohort study designed to compare neva sr with control sr for safety and effectiveness when removing thrombus in subjects presenting with acute ischemic stroke (ais) due to large vessel occlusion (lvo). the objective of the neva international, multi-center, retrospective comparative stent retriever (sr) study (nitro) study is to compare safety and effectiveness of the neva sr to commonly used sr with ce-mark, and us fda clearance, to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion. nitro aims to collect data describing real-world clinical practices when using srs according to their indicated use within the indicated population. as such, the eligibility criteria define patients who are diagnosed with ais and are indicated for endovascular mt aligning to the target population for the proposed device. the present study will include data from subjects treated with either neva sr or one of the control sr. control sr will include any sr commonly used in thrombectomy trials as first-line strategies and which represent ce-mark, and us fda cleared stent retrievers.

Eligibility criteria:
inclusion criteria: * treatment during the enrollment period * age ≥18 * baseline modified thrombolysis in cerebral infarction (mtici) score ≤ 1 * pre-stroke modified rankin score (mrs) of 0 or 1 * internal carotid artery (ica), middle cerebral artery (first segment m1/ second segment m2), basilar artery or vertebral artery occlusion * national institutes of health stroke scale (nihss) score ≥ 8 and ≤ 25 * thrombectomy procedure initiated within 8h of time last known well (tlkw) * intravenous tissue plasminogen activator (iv-tpa) failed, given within 3h of tlkw, or ineligibility for thrombolytic drug exclusion criteria: * first line contact aspiration alone or non-study device as first-line device

Keywords: neva mechanical thrombectomy
the effects of secondary smoking during one lung ventilation

Conditions: Smoking; Oxygen Deficiencies

Summary: smoking and perhaps secondary smoking is associated with many perioperative and postoperative complications, especially respiratory events. hypoxemia and airway damage can be associated with secondary smoking. the aim of study is to predict the incidence of hypoxemia and airway damage during one lung ventilation for lobectomy.

sixty patients undergoing lobectomy using one lung ventilation by double lumen tube will be included in this study. these patients will be divided into 2 groups. groups s which will be included non smoking and secondary smoking and group ss which will be included secondary smoking ( smoking near him more than 10 cigarettes per day fore more than 5 years). intra and postoperative arterial oxygen tension, arterial carbon dioxide tension and intraoperative peak airway pressure will be compared between the two groups.

Eligibility criteria:
inclusion criteria: * sixty patients undergoing lobectomy using one lung ventilation by double lumen tube, asa physical status 2 and 3. exclusion criteria: * recent chest infection, morbid obesity, renal, hepatic and ischemic hearts disease, asthma.

Keywords: secondary smoking one lung ventilation arterial oxygen tension lobectomy
real-time cad for colonic neoplasia: a rct

Conditions: Colorectal Cancer; Colorectal Neoplasms

Summary: this study assesses the sensitivity and added benefits of computer-aided detection compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.

failure in polyp detection leads to colon cancer after colonoscopy. artificial intelligence systems allow real-time computer-aided detection of polyps with high-accuracy. this study will compare gi-genius, a real-time cad system to standard colonoscopy in terms of how many colonoscopies detect an adenoma.

Eligibility criteria:
inclusion criteria: * undergoing colonoscopy at ruhs * age \> 45 years * no contraindications to colonoscopy exclusion criteria: * prior history of subtotal colectomy

Keywords: artificial intelligence
mri assessment of placental health

Conditions: Intrauterine Growth Restriction

Summary: the ultimate goal of this project is to develop methods that allow informed decision-making on the delivery time of fetuses that are at increased risk of stillbirth due to iugr. in placenta related iugr pregnancies, there can be multiple concurrent placental pathologies. although there is no specific correspondence between a single type of pathology and iugr, the common result of these pathologies is placental insufficiency, which limits the maternal-fetal exchange. oxygen and nutrition transport is known to be hindered in iugr placentas due to obstructed or abrupt vasculature, massive fibrin deposition, and inflammation in the villous and intervillous space (villitis). thus one potential approach to distinguish iugr pregnancies from normal ones is to assess the efficiency of placental transport. based on the hypothesis that efficiency of oxygen transport is representative for overall oxygen and nutrition transport in placenta, the investigators propose to characterize the blood oxygenation and blood perfusion in placenta in vivo via mri, and use it as an index for better stratification in the iugr risk group. the investigators will also consider alternative mri approaches such as structural, diffusion and spectroscopy measurements inside the placenta, which might reflect the state of placental transport and reveal the status of placental health. specific aims: 1) to correlate the mri metrics that differentiate placental insufficiency from normal placenta transport with histopathology data of the placenta. 2) to correlate the mri metrics that reflects placental insufficiency with fetal outcome


Eligibility criteria:
inclusion criteria: 1. the pregnant mother with twin gestation with diagnosis of selective iugr based upon obstetrical us findings as following: * proven monochorionicity / dichorionicity * discordance in estimated fetal weight (efw). growth restriction (\ or = 20%) between twin fetuses. 2. the pregnant mother with singleton gestation with diagnosis of iugr based upon obstetrical us findings as following: * proven singleton gestation * growth restriction of fetus (\<10 percentile of norm) * doppler measurements that indicates placental insufficiency: umbilical artery, middle cerebral artery, uterine artery; or oligohydramnios. 3. gestational age: bigger than 18 weeks. 4. pregnant mother is between age 18 to 45, clinically stable and can safely tolerate fetal mri study. exclusion criteria: fetuses/infants with the following features will be excluded. 1. fetus/infant with chromosomal anomalies or known genetic disorders. 2. fetus/infant with other major congenital malformation. 3. presence of any condition or abnormality that in the opinion of the investigator would compromise the safety of the patient, quality or completeness of the data. pregnant mothers with the following features will be excluded. 1. mothers with contraindication to mri (with pacemaker, metal in body, oversize). 2. mothers with claustrophobia 3. mothers medically unstable for the mri study
ablative therapy in the management of prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is collect observational data regarding patterns of care and outcomes of focal therapies for prostate cancer, including but not limited to: high-intensity focused ultrasound (hifu), cryotherapy, focal laser ablation, irreversible electroporation, photodynamic therapy, and brachytherapy.

through the use of a pro- and retrospective registry, the investigators will collect information on patient characteristics including age, co-morbidities, imaging and biopsy information, and prior treatments. information on treatment details will also be captured, including treatment time, anesthesia delivered, and length of stay, when applicable. oncologic outcomes including psa, post-treatment biopsy and imaging data, need for re-treatment, and survival outcomes will also be captured. safety outcomes will be captured using the clavien-dindo classification scale, and additional specific gu complications will be recorded, which include urinary retention, urethral stricture, recto-urethral fistula, osteomyelitis, and urinary tract infection. finally, the investigators will capture functional outcomes using health related quality of life questionnaires including the epic questionnaire, iief-5, mshq-ejd, and ipss.

Eligibility criteria:
inclusion criteria: * \>18 years of age * undergoing focal therapy for primary or salvage treatment of prostate cancer, or * have received prior focal therapy exclusion criteria: * clinically-evident metastatic disease * unable to fill out an english-language questionnaire

Keywords: prostate cancer cryotherapy focal therapy
pta-registry, a prospective, multicenter study with 24-month follow-up

Conditions: Efficacy/Long-term Effectiveness Endovascular Therapy in PAD

Summary: the pta-registry (pta-reg) is a prospective health services research registry to monitor and follow-up patients with peripheral arterial disease undergoing endovascular peripheral intervention. the pta-reg has an interdisciplinary approach: cardiologists, angiologists, and radiologists contributed actively to this registry.

the registry was created for the following purposes: evaluation of the clinical effectiveness, safety and quality of the endovascular therapy, and history of the disease after endovascular therapy. the resulting specific research questions were determination of the technical and clinical success of the procedure, monitoring of periinterventional complications, evaluation of vessel patency, amputation rate, mortality, and major adverse cardiac events during the follow-up. in addition, the quality of life after endovascular peripheral intervention over a period of two years was evaluated.

Eligibility criteria:
inclusion criteria: * peripheral arterial disease of the iliac and lower extremity arteries and appropriate clinical indication for treatment with pta according to current guidelines exclusion criteria: * no exclusion criteria and no age restriction

Keywords: pad, pta, mortality, morbidity, amputation rate, quality of life percutaneous transluminal angioplasty (pta), stenting, balloon angioplasty
neoadjuvant almonertinib followed by chemo-immunotherapy in ii-iiib egfr-mutant nsclc

Conditions: Non Small Cell Lung Cancer; EGFR Gene Mutation

Summary: phase ii, single-arm, open-label study that assess clinical feasibility and safety of neoadjuvant almonertinib followed by 3 cycles neoadjuvant adebrelimab plus chemotherapy in egfr-mutant stage iia-iiib nsclc followed by surgery, adjuvant treatment was upon investigators' decisions.

this study plans to include 32 eligible ii-iiib non small cell lung cancer (nsclc), patients will receive 6 weeks of almonertinib, and to avoid overlap of interstitial lung disease (ild) and immune-related pneumonitis, 2 weeks of washout period was designed before 3 cycles of adebrelimab + doublet platinum-based chemotherapy is administered. dynamic blood samples before, during or after neoadjuvant treatment will be obtained for exploratory analysis. patients with local disease and resectable or potentially resectable nsclc will receive anatomic resection. patients who progress upon neoadjuvant treatment and further assessed as unresectable disease will be scheduled for local radiation or other potential subsequent treatment regarding multidisciplinary discussion. after completion of local treatment (surgery or radiation), patients will undergo optional adjuvant treatment including epidermal growth factor receptor tyrosine kinase inhibitor (egfr-tki) or immunotherapy upon investigators' consideration or ct surveillance. patients will be follow-up within 5 years after surgery. the primary endpoint of this study is major pathological response (mpr) defined as no more than 10% residual tumor found in primary lung cancer as per international association for the study of lung cancer (iaslc) criteria.

Eligibility criteria:
inclusion criteria: 1. male or female，age: 18 years and older, 2. subjects voluntarily joined the study and signed informed consent, 3. pathological proven resectable stage ii-iiib non small cell lung cancer (ajcc 8th edition), 4. ecog ps=0 or 1, 5. resectable or potentially resectable, or resectability discussed by mdt, 6. harboring egfr mutation: ex19del, l858r, t790m, g719x, exon20 insertions, s768i or l861q 7. measurable lesion as per recist1.1. exclusion criteria: 1. pathologica or cytological proven small cell lung cancer, mixed small cell lung cancer or other than non small cell lung cancer, 2. non small cell lung cancer harboring other driver gene alteration with approved targeted drugs, 3. with malignant plural effusion, 4. previous treatment to non small cell lung cancer other than this regimen, 5. received thoracic radiotherapy, 6. currently enrolled in other clinical trial, 7. active or known or suspected autoimmune disease.

Keywords: non small cell lung cancer neoadjuvant therapy immunotherapy egfr
rtms for the treatment of chronic tinnitus: optimization by simulation of the cortical tinnitus network

Conditions: Chronic Tinnitus

Summary: transcranial magnetic stimulation is used to modulate both the auditory and non-auditory neural pathways contributing to the perception of phantom sounds.

tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. it is a frequent problem which can interfere significantly with the ability to lead a normal life. treatment remains difficult. most available therapies focus on habituation rather than treating the cause. tinnitus has been shown to be associated with functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system. consequently, low-frequency repetitive transcranial magnetic stimulation (rtms) applied to the temporoparietal areas has been investigated for the treatment of tinnitus. additionally, there is growing evidence that a neural network of both auditory and non-auditory cortical areas is involved in the pathophysiology of chronic subjective tinnitus. targeting several core regions of this network by rtms might constitute a promising strategy to enhance treatment effects. a new multisite treatment protocol which is supposed to have an effect on both auditory and non-auditory cortical areas will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a controlled pilot trial.

Eligibility criteria:
inclusion criteria: * diagnosis of subjective chronic tinnitus * thi \> 38 * duration of tinnitus more than 6 months exclusion criteria: * objective tinnitus * treatable cause of the tinnitus * involvement in other treatments for tinnitus at the same time * clinically relevant psychiatric comorbidity * clinically relevant unstable internal or neurological comorbidity * history of or evidence of significant brain malformation or neoplasm, head injury * cerebral vascular events * neurodegenerative disorder affecting the brain or prior brain surgery; * metal objects in and around body that can not be removed * pregnancy * alcohol or drug abuse * prior treatment with tms

Keywords: tinnitus chronic subjective tinnitus transcranial magnetic stimulation rtms hearing disorders
pk driven prophylaxis for hemophilia a

Conditions: Hemophilia A

Summary: the purpose of this study is to evaluate the implementation of pharmacokinetic (pk) driven prophylaxis in current clinical practice

starting from 3 pharmacokinetic (pk) points, data are entered in the pk calculator device, and treatment dose is adjusted following the results of pk values obtained and clinical bleeding data

Eligibility criteria:
inclusion criteria: * male patient * severe or moderately severe haemophilia a (fviii = 2 %), preventively treated (processing) by advate for at least 6 months, * at last 6 years old, * an informed consent must be signed by the patient or his legal representative for the patients minor. * affiliated to a national insurance scheme exclusion criteria: * previous or actual treatment with fviii inhibitors \> 0,6 ub at the selection * induction of immune tolerance * planned orthopedic surgery for the 18 next months * any other haemostatic pathology * any treatment interacting on the haemostasis * patient under guardianship * patient participating in another biomedical research

Keywords: hemophilia a prophylaxy pharmacokinetic bayesian